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Published: Monday, 10/1/2007

The right prescription

WITH millions of Americans taking prescription drugs, the ability to monitor and manage those medications is critical to patient safety. Now, Congress and the President have taken a step in the right direction by empowering the Food and Drug Administration to better police drugs already on the market.

President Bush last week signed a new drug safety bill, achieved with a high degree of bipartisan consensus, which gives the FDA expanded authority to act when problems emerge with a new medicine after its approval.

The move to shift more of the agency's attention from experimental drugs to after they reach the market follows a series of drug-safety controversies, including the withdrawal of the painkiller Vioxx three years ago after it was linked to heart attacks and strokes.

Congressional proponents of giving the FDA broad new powers to ensure drug safety said the development should be reassuring to every family concerned about the safety of drugs as well as possible side effects. And with serious drug reactions reportedly increasing, that apprehension is warranted.

According to a recent study published by the American Medical Association, the number of deaths and injuries from prescription drugs more than doubled from 1998 to 2005. It said the dramatic rise in reported "adverse events" - incidents resulting in death or serious injuries such as birth defects, disability, and hospitalization - indicates big problems with the way drugs have been monitored, not only before approval but after they're on the market.

One example is insulin. It was among the top drugs cited in the report for causing disability or other "serious outcomes." Improper usage of the medication, said the study's lead author, can cause low blood sugar, which can also lead to balance problems, accidents, and unconsciousness.

Thomas Moore, senior scientist for drug safety and policy at the Institute for Safe Medication Practices in Huntington Valley, Pa., concluded that both regulators and the medical community have long been in denial about drug safety. He found serious adverse event reports rose to 89,842 in 2005 from 34,966 in 1998. The number of "fatal adverse drug events" jumped nearly three-fold, to 15,107 in 2005 from 5,519 in 1998.

Just weeks ago, four deaths were linked to a newly approved FDA drug called Fentora. The manufacturer of the powerful painkiller said all four cases apparently involved improper use of the drug, which is approved only for cancer patients already taking morphine or other prescription narcotics for pain. None of those who died were cancer patients.

Clearly, the explosion of new drugs on the market requires greater diligence by the federal agency charged with monitoring them. Now, at least, the FDA is poised to substantially change the way it does business by adopting a more aggressive strategy to tackle drug-safety issues.

It's a welcome reform with a proactive approach that puts drug companies on notice that the agency will be no longer be passively monitoring but actively investigating the need for postapproval safety studies or new warnings on marketed prescription drugs if problems appear.

And the cost for the intensive regulatory efforts to review drugs and medical devices will rightfully be defrayed by extended and increased industry fees.



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